Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

August 2026 — CDMO Opportunities And Threats Report

Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

GUEST COLUMNISTS

What FDA Inspectors Want From Your OOS File
Read enough FDA warning letters and a pattern emerges: Investigators rarely cite a retest that was performed badly. They cite a retest that nobody justified in writing. Let's take a closer look.
You Can't CAPA What You Can't Classify
An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.
AI Fills The Decision-Making Gaps In Process Analytical Technology
When combined, artificial intelligence and PAT help move beyond reactive quality testing to proactive and anticipatory process management.
Is mRNA Manufacturing Overbuilt?
mRNA pipelines continue to advance, but has provider growth outpaced the pipeline? Let's take a closer look.
CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture
Discover strategies for risk-based governance, AI-enabled quality management, stronger collaboration, and fostering a culture that supports long-term operational excellence.
Using Digital Platforms To Find Your CDMO
In recent years, digital platforms have emerged to help pharma/biotech companies discover, evaluate, and connect with CDMOs more efficiently. These resources have different functions and limitations.
FDA Issues New Guidance On Therapeutic Equivalence
The FDA has issued a new guidance document, Evaluation of Therapeutic Equivalence, clarifying the scientific and regulatory principles. What does this mean for drug developers and manufacturers?
July 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

PHARMA OUTSOURCING WHITE PAPERS

SMB Technology: Optimizing API Purification
Explore how Simulated Moving Bed (SMB) technology can enhance API production while overcoming common misconceptions about chromatographic purification.

White Paper: Spray Drying Biologics: An Alternative To Freeze Drying
Explore how innovative drying technologies can enhance the stability and efficacy of biologics, ensuring successful outcomes in this rapidly growing sector of the pharmaceutical industry.
Spray Dried Biologics For Pulmonary Dosage Forms
Spray drying creates stable inhalable biologic powders with controlled particle size, enabling effective lung delivery, improved stability, and scalable production for respiratory and systemic therapies.
Innovation In Filtration
Filtration removes contaminants to ensure safety and is essential in various applications, from lab-scale tasks to GMP production. Explore how its simplicity and reliability make it indispensable.
Challenges And Solutions In Lyophilization Development For ADCs
Successful ADC lyophilization requires a robust, individualized process driven by thermal characterization using DSC and FDM to define the critical parameters for stability and efficient manufacturing.
Process Analytical Technology In The ADC Bioconjugation Process
Integrating Process Analytical Technology into validated GMP processes is complex and costly, which requires thorough validation of equipment and cleaning methods. Explore more about PAT's role in ADC production.